Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires

NCT ID: NCT01214876

Last Updated: 2011-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-03-31

Brief Summary

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A longitudinal study on immune responses in relation to protection against clinical malaria episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited: children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and above (n=125). After finger prick sampling (\~300µL) and examination at enrolment, participants will be followed up for one year. Follow-up will include fortnightly active case detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the associated clinical and parasitological parameters will be related to immunological profiles determined utilizing a protein microarray as a capture substratum to profile the humoral immune response against a vast number of parasite antigens.

For individuals who experience a clinical malaria attack or who are diagnosed with high density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood sample is obtained to determine the diversity of parasite antigens in the population in relation to antigen recognition in the cohort.

Detailed Description

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Conditions

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Malaria Schistosomiasis Hiv Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children 1-5 years old

No interventions assigned to this group

Children 6-10 years old

No interventions assigned to this group

Adults 25 years and above

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age 1-5 years, 6-10 years or 25 yearsand above
* written informed consent must be given
* the individual must have been resident of the area since birth or for a minimum period of two years
* the individual must be willing to submit required information and to participate in repeated sampling (total blood volume \~2.5 mL over a period of 12 months)
* Absence of danger signs (as defined by WHO) or clinical features of AIDS. An HIV-test will be offered to all participants at enrolment and completion of the study.

Exclusion Criteria

* unwillingness to sign consent form
* unwillingness to reside in the study area during the follow-up period
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Medical Biotech Laboratories

UNKNOWN

Sponsor Role collaborator

University Of Perugia

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Microtest Matrices Ltd

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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London School of Hygiene & Tropical Medicine

Locations

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Medical Biotech Laboratories

Kampala, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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FIGHTMAL

Identifier Type: -

Identifier Source: org_study_id

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